Manufacturing Services Process Technician (Day Shift) Multiple Positions

Amgen - Holly Springs, NC

Full-time - Entry Level

Remote - Holly Springs, NC

Chemical Manufacturing

About the position

At Amgen, we are committed to serving patients and driving innovation in biotechnology. As a Manufacturing Services Process Technician, you will play a crucial role in our manufacturing organization at the Amgen North Carolina facility. This facility is designed to be one of the most advanced drug substance manufacturing plants, integrating the latest disposable technologies with traditional stainless-steel equipment to maximize operational flexibility. The FleX Batch facility will not only utilize best-in-class drug substance manufacturing technologies but will also incorporate sustainability innovations aimed at reducing carbon emissions and waste, aligning with Amgen's goal of becoming a carbon-neutral company by 2027. In this vital role, you will initially work a Monday to Friday schedule of 8-hour days, with the potential for remote work. However, as business needs evolve, the schedule will transition to a 12-hour day shift, which may include working every other weekend. Your primary responsibility will be to support all floor operations in compliance with current Good Manufacturing Practices (cGMP). This includes performing hands-on operations, ensuring adherence to safety protocols, and maintaining a clean and organized workspace. As a Manufacturing Services Process Technician, you will be responsible for various tasks, including the preparation and transfer of buffers and media, weighing and dispensing materials, and completing documentation for assigned functions. Your role is essential in ensuring that all operations are conducted in accordance with established cGMP procedures and policies, thereby contributing to the overall success of our manufacturing processes.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies, including Standard Operating Procedures (SOPs) and Manufacturing Procedures (MPs).
• Ensure proper gowning and aseptic techniques are always followed.
• Perform hands-on operation including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
• Prepare and transfer buffers and media.
• Weigh and dispense materials for buffer and media preparation.
• Complete washroom activities, including cleaning equipment used in production activities.
• Run and monitor critical processes per assigned procedures.
• Perform documentation for assigned functions, such as equipment logs and Electronic Batch Records (EBRs).
• Maintain an organized, clean, and workable space.

Requirements

• High school diploma / GED with 1 year of manufacturing and/or other regulated experience, or an Associate's degree.
• Completion of NC BioWork Certificate Program (preferred).
• Experience in a regulated industry such as biotechnology or pharmaceutical (preferred).
• Basic understanding of GMP principles (preferred).
• Strong verbal and written communication skills (preferred).
• Proficient in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems (preferred).
• Ability to perform assignments with a high degree of focus and attention to detail.

Benefits

• Comprehensive employee benefits package including health, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements.